Senior CQV Engineer: Validate Facilities & Systems

BioSpace; Marlborough (MA); On-site; USD 89,900 - 143,800; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Holistic well-being support

Generous paid time off

Savings and investment opportunities

Job summary

A leading biotech company in Marlborough, MA, is seeking an individual contributor to lead commissioning, qualification, and validation (CQV) activities in a cGMP environment. The ideal candidate will have a Bachelor of Science in Engineering and over 5 years of experience in biopharmaceutical validation. Responsibilities include developing validation strategies, leading projects, and collaborating cross-functionally. Competitive salary range of $89,900.00 - $143,800.00, with excellent benefits, including healthcare and generous paid time off.

Qualifications

• 5+ years of experience in biopharmaceutical validation or related roles.
• Strong understanding of global regulatory requirements.
• Demonstrated ability to lead complex validation efforts.

Responsibilities

• Lead CQV activities for facilities, utilities, and analytical instruments.
• Develop and execute validation strategies for projects.
• Serve as SME during regulatory inspections.

Skills

Validation lifecycle principles

Technical writing

Cross-functional leadership

Problem-solving

Education

Bachelor of Science in Engineering

Job description

A leading biotech company in Marlborough, MA, is seeking an individual contributor to lead commissioning, qualification, and validation (CQV) activities in a cGMP environment. The ideal candidate will have a Bachelor of Science in Engineering and over 5 years of experience in biopharmaceutical validation. Responsibilities include developing validation strategies, leading projects, and collaborating cross-functionally. Competitive salary range of $89,900.00 - $143,800.00, with excellent benefits, including healthcare and generous paid time off.